Job Description

SUMMARY

The Senior Clinical Database Specialist is responsible for independently performing data management tasks, including clinical study database design and build, as well as providing oversight and leadership to support both in-house and outsourced clinical trials.

Develop Clinical Data Management timelines (with management approval) including interim and final database lock and data reviews; monitor overall data management tasks to ensure that timelines are met and that any issues are proactively identified and resolved.

Requirements

Qualifications

Comprehensive knowledge of data management practices from protocol design to database development. Proficiency with Medidata Rave (including Architect, Amendment Manager, and Targeted SDV); intermediate knowledge of Business Objects and SQL; general understanding of SAS. Experience working under Good Clinical Practices, Good Clinical Data Management Practices, CDISC/CDASH/SDTM, and other FDA guidelines is required. Demonstrated solid oral and written communication skills and analytical/problem-solving skills are essential as is the ability to clearly communicate basic data management concepts to those outside data management. Must be able to effectively manage multiple projects and timelines. Must be able to travel up to 5% per year. Requires the ability to sit or stand while working on a computer for a long period of time.

Bachelor’s degree in computer sciences or a scientific discipline with a minimum of 6 years of experience in an in-house bio-pharmaceutical clinical data management position is required. Additional experience working at or managing vendors/CROs is a plus.